Pancreatic Necrosis, Pancreatitis
Conditions
Keywords
Direct Endoscopy Necrosectomy, Transgastric Surgical Necrosectomy, Powered Endoscopic Debridement, Pancreatic Necrosis, Walled of Pancreatic Necrosis, Necrotizing Pancreatitis
Brief summary
Goal: The goal of this clinical trial is to compare the effectiveness and safety of two different but highly effective treatment approaches for walled-off necrosis (WON) resulting from severe acute pancreatitis. Participant Population: The study will involve adult patients experiencing symptomatic WON due to acute necrotizing pancreatitis. Main Questions: The main questions it aims to answer are: 1. Is "endoscopy" or direct endoscopic necrosectomy (DEN) with powered endoscopic debridement (PED) as effective as "surgery" or transgastric surgical necrosectomy (SN) in achieving clinical resolution of WON within six weeks after treatment? 2. What are the rates of complications, costs, hospital length of stay, procedure time, readmission, repeat procedures and overall patient satisfaction associated with DEN with PED compared to transgastric SN? Comparison Group: Researchers will compare the outcomes of patients receiving DEN with PED to those undergoing transgastric SN to see if there are significant differences in clinical success, rates of complications, and overall healthcare costs. Participants Will: 1. Be randomly assigned to one of the two treatment groups (DEN with PED or transgastric SN). 2. Undergo the assigned treatment procedure based on their group. 3. Complete assessments before and after the procedure to evaluate clinical outcomes, hospital stay length, quality of life, and patient satisfaction. 4. Be monitored for adverse events or complications following the treatment
Interventions
DEVICEDirect Endoscopic Necrosectomy with Powered Endoscopic Debridement
Patients will first undergo endoscopic ultrasound-guided cystgastrostomy using an electrocautery-enhanced lumen apposing metallic stent to gain access to the necrosum. Direct Endoscopic Necrosectomy will be performed using the EndoRotor® NecroMax 6.0 PED Catheter which has an outer diameter of 5.1 mm and is compatible with endoscopes that have a working channel of ≥6.0 mm.
PROCEDURETransgastric Surgical Necrosectomy
Patients randomized to the surgical arm will undergo open or minimally invasive (laparoscopic) transgastric SN with the aim of creating an ample size cystgastrostomy to perform a complete debridement. In either approach, the peritoneal cavity is entered to identify the stomach through which an anterior gastrotomy is made. The retrogastric necrosum is identified either using a finder needle or ultrasound and accessed through a posterior cystgastrostomy. Transgastric SN is then manually performed, and any cyst fluid fully evacuated. The anterior gastrotomy is then closed allowing any residual necrosis or pancreatic enzyme to efflux into the stomach and enter the upper GI tract. As with endoscopy, patients with retrogastric collections are observed for a sufficient period to ensure full maturation of the necrosum.
Sponsors
Stanford University
Indiana University Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Biostatistician will be blinded to the study groups while performing final study analysis.
Intervention model description
"Endoscopy" arm will receive direct endoscopic necrosectomy and "Surgery" arm will undergo transgastric surgical necrosectomy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age or greater. * Patients with first episode of symptomatic WON+ due to acute pancreatitis (+Persistent fatigue, malaise, abdominal pain, gastric outlet obstruction, early satiety, fever, chills, jaundice, reduced appetite, persistent nausea/vomiting, steatorrhea) * Patients who are candidates for surgical or endoscopic necrosectomy of WON as deemed by a multidisciplinary committee of HPB surgeons and therapeutic endoscopists. * Patients who can tolerate repeat procedures. * Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.
Exclusion criteria
* Documented untreated pseudoaneurysm within WON. * Subject unable or unwilling to provide informed consent. * Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using pre-procedural imaging). * Coagulation disorders or anti-coagulant therapy which cannot be discontinued for the intervention to an absolute cardiac or vascular indication such as ACS, Stroke, Mechanical cardiovascular valves. * Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation. * Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial. * Non-communicating pancreatic or extra-pancreatic fluid collections. * Extensive abdominal surgical history due to peritoneal adhesions, prior open or recent operation during pancreatitis course, or remote gastric surgery that precludes a transgastric surgical cystgastrostomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success at 6 weeks after Debridement | From initial intervention to 6 weeks | Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions. AND Radiographic resolution defined as \>70% reduction in WON on CT or MR imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall treatment success rate at end of 6-month follow-up from date of intervention | From initial intervention to the end of followup at 6 months | Clinical resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions after completion of 6-month follow-up. AND Radiographic resolution defined as \>70% reduction in WON on CT or MR imaging after completion of 6-month follow-up. |
| Clinical improvement within 72 hours of debridement | From initial intervention to 72 hours after treatment | Clinical improvement is defined according to the criteria used in the PANTER and TENSION trial. (8-10) "Clinical improvement" defined as: i. Improved function of at least two organ systems (i.e. circulatory, pulmonary, renal) according to the Investigator's medical judgement within 72 hours of the procedure, or; ii. At least 10% improvement of two out of three parameters of infection (i.e. C-reactive protein, leucocyte count or temperature) within 72 hours of the procedure. Deterioration of these parameters by other infectious causes (e.g.urinary tract infection) will be excluded. |
| Clinical Failure at 6 months | From initial intervention to the end of followup at 6 months | Absence of clinical improvement or clinical deterioration |
| 30-day mortality | From initial intervention to followup at 30 days | Mortality occurring at 30 days after intervention |
| Overall total cost of care | From initial intervention to the end of followup at 6 months | Cost of care per patient to achieve overall treatment success |
| Overall cost of care at 6 weeks | From initial intervention to followup at 6 weeks | Cost of care per patient to achieve overall primary outcome |
| Percent reduction in WON collection volume (cm3) at 6-month follow-up | From initial intervention to the end of followup at 6 months | Percent reduction in overall size of the WON collection volume (cm3) compared to pre-treatment CT or MR imaging. |
| Percent resolution of solid necrosum in patients with pre-and post-MR imaging at 6-month follow up | From initial intervention to the end of followup at 6 months | Percent reduction in solid necrosis component of the WON collection volume (cm3) compared to pre-treatment MRI scan. |
| Post-procedural length of hospitalization (recovery time) | From index intervention to hospital discharge at 6 weeks | Length of hospitalization from index intervention to hospital discharge |
| Readmissions | From initial intervention to the end of followup at 6 months | Number of hospital readmissions due to disease or procedure-related symptoms or events. |
| Reintervention rates | From initial intervention to the end of followup at 6 months | Need for endoscopic, radiological, or surgical intervention for additional drainage or necrotic debridement after the index intervention, excluding the follow-up procedure at 4-weeks for LAMS removal |
| Requirement of percutaneous drain | From initial intervention to the end of followup at 6 months | Need for additional drainage with percutaneous drain |
| Total anesthesia duration | On day of intervention (1 day) | Total duration of anesthesia of primary intervention |
| Procedure-related adverse events | From initial intervention to the end of followup at 6 months | Any adverse event resulting from endoscopic intervention (yes/no) |
| Disease-related adverse events | From initial intervention to the end of followup at 6 months | Any adverse event resulting from necrotizing pancreatitis |
| Patient satisfaction | From initial intervention to the end of followup at 6 months | Patient satisfaction of primary intervention at 6 weeks post intervention graded on a visual analog scale (0-10) |
| Subject quality of life (QOL) | From initial intervention to the end of followup at 6 months | Quality of life survey to participants at 6 month follow up. Patients will be asked to place a mark on a horizontal 10 cm line indicating his/her QoL from very poor to very good. The wording will be: "How would you rate your overall quality of life?". Higher score indicates very good quality of life and lower score indicates poor quality of life. The instrument is valid and has been used in clinical trials. |
Contacts
PRINCIPAL_INVESTIGATORJoo Ha Hwang, MD, PhD
Stanford University
Outcome results
None listed